Pick a Good Problem: Mobisante's Approach to Mobile Health

For Nikhil George, chief engineer at Mobisante, developing an mHealth application or device starts with a simple premise: find a worthwhile problem and solve it. These days, with more and more fitness trackers hitting the market, consumers and patients are going to be looking more and more for devices that stand out from the pack. It's up to developers to deliver this, but with FDA announcing that it will only be regulating a small subset of mobile health apps, its easy to see the financial incentive against developers taking the road less traveled. Why go through the tedium of FDA, even via a 510(k), to create a novel mobile medical solution when you can blast another sleep tracker, heartbeat monitor, or diet tracker into the already bloated app marketplace?

Add a physical device into the mix and it becomes even more costly and laborious. Companies like Dexcom are moving away from hardware into software, in part because the length of the hardware development cycle makes it difficult to keep up with consumer trends and expectations – no one wants a device in their pocket or strapped to their body that's any larger (or less stylish) than their cellphone.

So how are developers looking to innovate in the space supposed to proceed?

“One really basically thing one has to keep in the back of one's mind is you need to start with a very real customer opinion and move from there.” says George, who will be speaking at Wireless Medical Devices West, “When you take that approach and you're brutally honest with yourself about the fact that you have a real customer opinion then you lessen your chance of you coming up with something not effective or less effective.”

Mobisante made waves beginning in 2011 when it became the first mobile-based company to gain FDA approval. The product is the MobiUS SP1, the first smartphone-based ultrasound system. The SP1 is a proprietary smartphone platform with a connected transducer for taking ultrasound readings in a small, portable system. Clinicians can use the device to perform eight different types of ultrasound exams at the point of care including abdominal (AAA), emergency or trauma (FAST), obstetric (OB), cardiac,vascular, small organs, and pelvic ultrasounds. Images and video from scans can be viewed on the device or saved and transferred to a PC for later viewing. In September Mobisante also announced the TC2, a tablet based ultrasound system.

George, who has a background in electrical engineering and computer science, joined Mobisante soon after the company was founded. At the time the SP1 only existed as a research prototype built at Washington University in St. Louis. “My job was to convert the research prototype into a shipping product; to commercialize the technology,” George says. He says the process involved a lot of interaction with clinicians to make sure Mobisante was creating a useful and effective product. “The thing that may be unique to building medical products, especially regulated medical products, is working through all the GMP issues, because the quality bar for a medical device is way higher than the quality bar for a typical off-the-shelf mobile app.”

George continues. “Along the way we handed out data of the product to actual physicians and our target customers to get feedback, and made a bunch of changes based on that - not just feedback on the concept, but on the prototype. Once we had a prototype we started working with FDA to get our 510K clearance.”

But going from zero to mobile application is often not the most straightforward, or even worthwhile, road, at least right now. The field is still so new that a lot of companies are quick to jump into the digital health / quantified self bandwagon and are effectively throwing products against a wall to see what sticks. Even at this early stage it can be easy to accuse the mHealth marketplace of becoming overblown with too many devices and apps that are too similar to each other or even outright ineffectual for patient outcomes.

But George encourages critics to look at the broader spectrum and the variety of problems that can be addressed within. “Whenever a new field like digital health or mHealth opens up and takes root, what you see is there's a lot of people with a lot of ideas and theres no way to figure out what works without actually trying it out,” George says. “We do need the kind of work to formally evaluate the effectiveness of things, but I wouldn't paint the whole mobile arena with the same brush because the span of technologies is really, really huge. It ranges from consumer applications in a wellness space, for example, all the way up to our kind of applications where we're building a regulated medical device.”

For Mobisante, the decision to enter the marketplace came in the face of hard data and evidence showing a need for a solution in their space. “If you look at the area that Mobisante plays in, which is point of care, (point of care ultrasound even before we came on the scene there was a lot of data and published research that showed that if you had point of care devices, specifically point of care ultrasound devices, it would reduce the cost of care, the length of hospital stays, and improve patient outcomes,” George says. “That was one of the principle reasons we got into the space. We had a point of care technology and we knew going that we could make this kind of difference.”

-Chris Wiltz, Associate Editor, MD+DI
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